January–March 2026, Group
Amounts in parentheses refer to the year-earlier period.
Significant events during the quarter
Significant events after the reporting period
A message from the CEO
Dear shareholders,
We took several important steps in the first quarter of 2026 toward our ultimate goal of obtaining market approval for our products and making them available for all of the patients who truly need them.
Physicians confirm that there is a real need in the market
During and after the quarter, we held in-depth conversations with hematologists in the US – both through Advisory Boards and at conferences such as NCODA Global Congress 2026. These conversations provided me with more than just crucial strategic input. They have further strengthened my conviction that what we have achieved during our nearly 20 years fulfills a highly significant clinical need in the market.
In our analysis of real clinical patient data – corresponding to more than 35,000 patient-years – we are seeing a clear pattern that physicians can understand but rarely see quantified. Patients often switch treatments at an early stage – in most cases due to side effects. One widespread and underestimated problem is co-medication with proton-pump inhibitors (PPIs). A large proportion of all CML patients treat stomach problems with PPIs while taking dasatinib – which drastically impairs the uptake of the crystalline drug. This is an everyday clinical problem that currently lacks a good solution. The reaction from physicians when we presented this data and demonstrated how Dasynoc® addresses this problem was clear and straightforward – not politely interested, but genuinely engaged. Having persuasive clinical data in an application is one thing. Hearing the physicians who will soon be prescribing the product say that their patients actually need this, is another.
Regulatory status – we are close
We enter the second quarter with optimism. Two products are very close to approval. The PDUFA date for Dasynoc® is set to August 25, 2026, and for Nilopki® (XS003 nilotinib) to June 18, 2026. Our manufacturing partner in Italy is expected to be inspection-ready during the first half of the year. If the FDA is able to complete the inspection before the PDUFA date, approval could come as early as June 18. If the inspection instead takes place after the PDUFA date, the FDA is likely to issue a CRL (Complete Response Letter) that relates solely to the inspection and not to the product itself.
As soon as the inspection is approved, Xspray will inform the FDA that no remaining obstacles to approval exist. Both paths are consistent with Xspray's plan to launch in the U.S. during the second half of 2026.
We are following the situation closely and are well prepared for a dual launch of Dasynoc® and Nilopki® in the autumn of 2026.
The HyNap platform is stronger than ever
Having two NDA applications under review at the same time, for two separate products based on the same technology platform, is something quite unique – especially for a company of our size. With every regulatory response we formulated, and every CMC question we answered, we have built up a knowledge base that is now clearing a shorter – and less costly – path for the next product candidates.
Financing
The completed preferential rights issue will secure the capital requirement up through launch and give us the resources needed to genuinely start up commercial operations with full force. Additional financing – for example, in the form of loan financing – may be needed to complete a successful double launch and achieve cash-flow positivity. Our cost structure is suitably adapted to keep running costs down, with launch-related investments being capitalized in line with future approvals.
Looking ahead
Now that the company is entering an eagerly awaited commercial phase, I would like to welcome Blake Leitch as our new CEO – the right person, at the right time. I, myself, am looking forward to focusing on the technology and the science, and to developing the next generation of improved PKI drugs in my role as Chief Scientific Officer.
In conclusion, I would like to say that leading an organization with so many competent and committed people has been a glorious journey. There is no doubt in my mind that, scientifically and technically, we have essentially done everything correctly. What we sometimes underestimated was the methodology. In breaking new ground, it is easy to assume that the business environment is keeping pace, that partners understand the implications of what we are doing, and that government authorities are sending the right expertise to audit us. This has not always been the case, and it has cost us time and money. We have every reason to believe that this phase is now behind us. The dialogue with the FDA has matured, the technology has been established and documented, and our take-aways from this journey will shorten the path to market for the next products. Now, it is a matter of transforming all this into successful commercialization and a strong pipeline, and I am genuinely looking forward to the next phase.
Thank you all for your confidence.
Per Andersson
CEO